,-
CLOSEOUT FOR M92010005
Associate Provost for Research at
investigation of alleged misconduct by I -1
-
This case was brought to OIG on October 9, 1991, when Dr.
University, informed us that the university was initiating an
Attached are the OIG investigation report, including its appendices
and the letter of reprimand from NSF to the subject, which explains
NSF1s adjudicative decision. These documents explain the actions
subsequently taken by OIG and NSF in this case.
cc: Deputy AIG-0, IG
page 1 of 1
. .
. . - . NATIONAL SCIENCE FOUNDATION'
4201 WILSON BOULEVARD
ARLINGTON, VIRGINIA 22230
OFFlCE OF M E
ASSISTANT DIRECTOR
BIOLOGICALSC~WCES
-
CERTIFIED MAIL -- RETURN RECEIPT REOUESTED
Re : Notice of Misconduct Determination
Dear Dr.
The National Science Foundation1s Office of Inspector General (OIG)
issued an Investigation Report on June 28, 1995, in which it found
that you committed misconduct in science. Based upon
investigations conducted by the Special Review Board and the
Institutional Review Board (IRB) of the -university,
and its own independent investigation, the OIG found that you
committed serious violations of the requirements for the protection
of human subjects. We have reviewed the report and conclude that
you have committed miscbnduct in science.
Misconduct and Pro~osedAction
Under NSF's misconduct in science and engineering regulations,
"misconduct" is defined to include "fabrication, falsification,
plagiarism; or other serious deviations from accepted practices in
proposing, carrying out or reporting results from activities funded
by NSF." 45 CFR §689.1(a).
The Agency's administrative record establishes that you failed to
comply with the IRB guidelines by failing to respond to the IRB1s
requests for consent and assent forms, failing to pay research
participants as promised, and failing to.obtain consent from a
school system to perform research on their students. You violated
the usual and customary practices for treating human subjects.
This cons'titutes a serious deviation from accepted practices for
the treatment of human subjects, and, therefore, scientific
misconduct.
NSF's regulations establish three categories of actions (Group I,
I1 and 111) that can be taken in response to a finding of
misconduct. 45 CFR §689.2(a). Group I actions include issuing a
letter of reprimand; conditioning awards on prior approval of
particular activities from NSF; and requiring certification on t h e
accuracy of reports or assurances of compliance with particular
requirements. 4 5 CFR §689.2(a)(1). Group I1 actions include
Telephone (703)306-1400 FAX (703)306-0343
Page 2
restrictions on designated activities or expenditures and special
reviews of requests for funding. 45 CFR 5689.2(a) (2). Group I11
actions include suspension or termination of awards; debarment or
suspension from participation in NSF programs, and prohibitions on
participation as NSF reviewers, advisors, or consultants. 45 CFR
5689.2 (a)(3).
In deciding what response is appropriate, NSF considered the
seriousness of the misconduct; whether it was deliberate or
careless; whether it was an isolated event or part of a pattern;
and whether the misconduct affects only certain funding requests or
has implications for any application for funding involving the
subject of the misconduct finding. See 45 CFR 5689.2 (b).
In this case, we do not believe that your failure to pay research
partici~ants.was a pattern of non-payment. However, the record
demonstrates that your failure to comply with the IRB requirements
for protection of human subjects was part of a pattern of non-
compliance with NSF grant conditions. You violated NSF grant
conditions by using NSF funds to perform research other than that
proposed to NSF, misusing funds that were allocated for payment of
research participants, failing to secure the safekeeping or return
of University owned equipment purchased under the NSF grant, and
failing to cooperate with Special Review
Board and IRB inquirieud *investigations concerning your
activities.
Based upon the above facts, I conclude that as a condition to your
receipt of future NSF funds, special grant conditions must be
implemented to protect NSFts interests as well as those of human
subjects. Accordingly, I will require, until January 1, 1998, that
NSF, before making an award in which you are named as the principal
investigator, shall require the grantee institution to establish
and enforce special procedures to monitor your compliance with
, NSF's grant conditions. These procedures shall, at a minimum,
provide for monitoring of your compliance with human subjects
research requirements and proper distribution of any federal funds
under your direct control. Such procedures must be approved in
advance by NSF.
procedures Governinq Appeals
Under NSF1s regulations, you have 30 days after receipt of this
letter to submit an appeal of this decision, in writing, to the
I Director of the Foundation. 45 CFR §689.9(a). Any appeal should
be addressed to the Director of the National Science Foundation,
4201 Wilson Boulevard, Arlington, Virginia 22230. For your
information we are attaching a copy of the applicable regulations
and of OIG' s investigative report. If you have any questions about
the foregoing, please call Lawrence Rudolph, General Counsel, at
(703) 306-1060.
Sincerely,
Mary E. Clutter
Assistant Director
Attachments (2)
Misconduct in Science Regulations
Investigation Report
NSF OIG REPORT
OIG Case Number M92010005
This document is loaned to you for official use only. It remains the property of the Office
of Inspector General. It may not be reproduced. It may be disclosed outside of NSF only
by the Inspector General, pursuant to the Freedom of Information and Privacy Acts, 5
U.S.C. $8552, 552a.
REPORT OF INVESTIGATION INTO AN ALLEGATION OF MISCONDUCT IN
SCIENCE AND ENGINEERING
SUMMARY
The Office of Inspector General (OIG) has determined that
- 1 (the subject) committed serious violations of human
subjects regulations; mishandled funds and equipment that were part
of an NSF award; did not, during the time she was receiving NSF
support, conduct the research she proposed to NSF; and did not
cooperate with inquiries and investigations concerning her
activities. These conclusions are based on investigations
performed by the subject's former university and by OIG. OIG
recommends that NSF find that the subject's violations of human
subjects regulations are misconduct and take the following actions
as a final disposition in this case. The subject should be told
that NSF has made a finding of misconduct and should receive a
letter of reprimand from the NSF Office of the Director. Until
January, 1998, before making an award in which the subject is named
principal investigator, NSF1s Office of the Director, in
consultation with scientists knowledgeable about research involving
human subjects, should require that the grantee institution
establish and enforce special procedures to monitor the subject's
compliance with NSF1s grant conditions, including, but not
necessarily limited to, procedures for monitoring her compliance
with human subjects replations at the grantee institution.
TBE UNIVERSITY'S INQUIRY AND INVESTIGATION
Early in 1990, members of at least three families complained
, -promised
to a (the University) that they had been
payments for their participation in experiments run by Dr.
-
(
t
h
e subject) and had not been paid. The subject's
experiments were performed under NSF award, 1-4 entitled
.At the time
-t
n) , where she
ter repeated,
unsuccessful efforts by officials at the University to verify and
settle the participants1 claims for payment, the chair of the
subject's department referred the matter to the University's
Research Integrity Committee, which conducted an inquiry. The
committee, in turn, referred the case to a Special Review Board,
which conducted an investigation.
A copy of the Board's investigation report appears in
Appendix 1. The Board's report contains sixteen appendices, each
identified by a letter (A-P). References to numbered appendices
page 1 of 24
indicate appendices to OIG's investigation report; where
appendices are identified by a letter, this indicates that they are
appendices to the Special Review Board (the ~oard)report and can
be found in Appendix 1. Quotations in OIGfs report, unless
otherwise indicated, are from the Special Review Board report or
its appendices, and page references refer to that report as well.
The Board report concluded (pages 22-23) that the subject had
committed Itscientificmisc~nduct'~ in the following respects:
1. She had !Imisused funds advanced to her for the purpose of
paying human research subjectsm and "repeatedly and
significantly1!violatedprocedures she and the university
had established governing her use of her research
checking account.
2. Using grant funds, the subject made an unjustified
purchase of video equipment and failed "to secure the
safekeeping of the equipment." Although the equipment
was University property, the Board could not locate it.
3. The subject "violated the usual and customary
requirements for the treatment of human subjects.I1 The
Board referred allegations of human subjects violations
to the University Institutional Review Board for the
.
. Protection of Human Subjects (IRB) The IRB found seven
instances in which the subject violated its guidelines.
A copy of the IRB report appears in Appendix 2.
4. There was I1no evidence1!that the subject had performed
the research she had proposed to NSF.
5. The subject did not cooperate with the Special Review
Board investigation or with other related inquiries,
including the IRB inquiry.
li The Bsard's report describes the subject's research and the
basis for the Board's findings. It is essential reading for making
decisions concerning this case.
he -Universityt
s I1Policyand Procedures for Review of Alleged
Misconduct in Research and/or ScholarshipIt define llscholarly
misconductt1as "fabrication, falsification, plagiarism, deception
or other practices that seriously deviate from those that are
I commonly accepted within the scientific community for proposing,
' conducting, or reporting research [footnote omitted] or (b)
material failure to comply with federal, state or other
requirements that uniquely relate to the conduct of research or (c)
misconduct in science. The university does not define llmisconduct
in sciencen or "scientific misconductM as such.
page 2 of 24
I
Because the subject was no longer employed by the University
at the time the Special Review Board report was completed, the
Board recommended no University action against the subject except
that "the General Counsel . . . take the necessary legal action to
recovern inappropriately spent funds from the subject . For the
same reason, the IRB report recommended no actions against the
subject.
The Board also recommended that NSF conduct its own
investigation and suggested that NSF might be able to elicit or
compel the subject's cooperation. The Board recognized that its
own investigation was hampered by the subjectls repeated failure to
cooperate and noted that, if the subject cooperated with NSF, a
'more complete description of the facts might be obtained. The
Board made the following recommendation (pages 24-25) to NSF:
On the basis of the evidence summarized in this report, the
Board suggests imposing two of the sanctions listed in Group
I of NSFfs misconduct regulations. . . .
NSF should (a) send
a letter of reprimand to [the subject]; and (b) for some
specified period, require as a condition of future awards that
an institutional official certify the accuracy of reports
generated under the award and provide assurance of [the
subjectlsl compliance with institutional, federal, and
professional standards, policies, guidelines, regulations, or
special terms and conditions relating to treatment of human
subjects (including recruitment, obtaining informed consent,
and payment), disbursement of funds, accounting, and
maintenance of pertinent records and documents. In addition,
on the basis of additional information that may be obtained
upon completion of its own investigation, NSF may wish to
consider possible sanctions listed in Group 111, including
debarment of [the subject] from participation in NSF programs
for some specified period.
OIG'S INVESTIGATION
Two OIG staff members, one of them a Ph.D. behavioral
scientist, questioned the subject concerning the findings in the
Special Review Board and IRB reports. The subject provided OIG
with a sworn statement concerning her activities under her NSF
award. A copy of this statement appears in Appendix 3. OIG1s
scientist also accompanied the subject to her office at her current
institution, where the two of them searched for records bearing on
page 3 of 24
her activities under her NSF award.2 OIG also audited the
university's expenditures under the subjectfs NSF award. A copy of
the audit report appears in Appendix 4.
In order to understand the evidence bearing on the
university's conclusions in this case, it is important to
understand the subject's research activities in 1989 (when she was
at her former university) and early 1990 (after she had moved, in
early January, to her new institution). During this period, the
subject either was or claims to have been engaged in data
collection for the following studies:
F
that NSF
study. This is the study design that the
ject proposed to NSF. It is the only study design
agreed to fund. It involved interviewing
members of one hundred families with two.parents and two
adolescent children.
2. This study involved
ool students.
-
3. This study involved interviews with "three-member
family groups composed of a female college student,
, and . (Board report,
page 14)
-
4. This study involved
In~erv-iews
with hxgh school and college students.
5. This study involved interviews with
young people about their expected m-
6. .-intekiews This study involved videotaped
with family groups. It w a s designed in
collaboration with another faculty member at the
2~hesubject supplied copies of all relevant records that they
could locate in her office or in storage rooms at her current
institution. The subject had not prepared a collection of research
records that she considered relevant in advance of OIGfs visit,
and, to facilitate the search for relevant files, generally
? permitted OIG1s scientist to examine her files without herself
screening them in advance. There is no reason to believe that the
subject either deliberately withheld relevant records or carefully
selected only certain records in order to document her own account
of her activities. Indeed, she supplied many records that
undermine her account, and she seemed imperfectly aware of the
contents of what appeared to be long unopened boxes of files that
she had brought with her from her former university.
page 4 of 24
subjectls former university. This study was discontinued
when the other faculty member left the subject's former
institution.
For a more detailed description of these studies, see the
Board report (pp.14-20). OIG believes that data for studies #2 and
# 4 were collected in 1989, as were a large part of the data for
study #3. OIG believes that, despite the subject's statements to
the contrary, the data for studies #1 and #5 were collected well
after the subject arrived at her new institution and without the
aid of her NSF award. The basis for these conclusions is discussed
below.
Evidence Bearing on the University's Conclusions
A summary of the evidence that relates to the five conclusions
of the Special Review Board follows.:
1. Misuse of funds set aside for human subjects
reimbursement.
Shortly after the subject was notified that NSF would make an
award, she sought to establish a checking account from which she
could draw funds to pay participants in her experiments. Appendix
J contains a copy of the subject's explanation to the University
Purchasing Office of why she needed this account. The subject
states:
A critical aspect of meeting this NSF grant obligation
involves the prompt reimbursement of research participants.
Because obtaining the full sample for this study depends
largely on referral of new families received from previous
participants, it is critical that individual reimbursements be
paid at the conclusion of completed interviews rather than
after a lengthy delay. Delays in payment of participant
reimbursement would have the effect of diminishing the
necessary referrals and undermine our ability to successfully
complete this grant.
The subject's justification for establishing the checking account
specifically restricts the use of account funds to interviewer
travel ($300) and human subject reimbursement ($6000). The account
required special justification in part because the subject, in
furtherance of her research objectives, was asking the university,
in the words of OIG1s audit report (page 8), to depart from
"prudent business practices and good internal controls1'and thereby
to increase "the risk,ofloss or misuse of fundsu (see audit report
in Appendix 4 ) .
page 5 of 24
At the Special Review Board1s request, the university1s
internal audit staff analyzed expenditures from the subject's
checking account (see Appendix P). During 1989, when the subject
was at the university and, at various times, employing three
different research assistants under the grant and receiving
additional research assistance fromtwo other graduate students and
several undergraduates, only four checks, totalling $20, were
written directly to research subjects. An additional six checks,
totalling $844, were written to the subject's research assistants,
who told the review board that they had used this money to pay
research subjects. The subject wrote two checks to cash, endorsed
by herself, totalling $800, with memo lines indicating that they
were used for subject reimbursement.
When an OIG scientist visited the subject's office, the
" subject produced copies of consent and assent forms signed by
persons who participated in her.research in 1989 and receipts for
payments to those persons. These forms and receipts relate to
three "ancillary studiesn that are thematically similar to the
project the subject proposed to NSF but are not included in her NSF
proposal (These studies are referred to above [page 41 as studies
#2, # 3 , and #4). OIG believes that the preponderance of the
evidence indicates that most or all of the money withdrawn from the
checking account in 1989 was used for paying research participants
in these ancillary studies and reimbursing interviewers for travel
connected with these ~tudies.~
3 ~ h econsent and assent forms and receipts that the subject
supplied corroborate the testimony of the subject's research
assistants (Appendix C) concerning her data collection activities.
The amount of money charged to the checking account for
participant reimbursement in 1989 is roughly consistent with the
amount that would have been necessary to pay the participants from
whom the subject obtained data and for whom she produced consent or
assent f o m or receipts for payment. OIG did not tally the
receipts against the withdrawals from the bank account because we
believe that a discrepancy would be as likely to indicate that some
receipts were missing as it would that money was misappropriated.
In her affidavit, the subject maintains that her 1989
withdrawals from her checking account were made for the purpose of
reimbursing some or all of 91 families from her former university's
state who were interviewed for the NSF study design. She
acknowledges that "the amounts I withdrew for . . . reimbursement
from the checking account are less than those which would have been
necessary to pay 91 families $10 or more per person. At this time
I cannot recall where the money came from to pay the remainder of
(continued.. .)
page 6 of 24
3
.
( . .continued)
the subjects participating in the study." This claim contradicts
the evidence on at least two counts. First, there is no evidence
that the subject collected any significant amount of data under the
NSF study design while she was at her former university. Second,
both the subject' s former research assistants and the check records
indicate that much of the money in the account was used to
reimburse participants in the ancillary studies. On page 4 of the
subject's affidavit (Appendix 3 ) ' she characterizes the testimony
of the research assistant who collected data ydu
for
ts(' #3)
as "substantially accurate." That research assistant said that she
I
reimbursed participants in 0 research with money derived from
the subject's checking account.
The subject's written reports of her research are further
evidence that she interviewed human subjects for the three
ancillary studies and are consistent with the idea that she did so
in 1989 and reimbursed subjects for their participation with monies
subject's co-authorwas one of her research assistants in 1989, and
the subject supplied assent forms and receipts for subject
reimbursement for this study. There is, in short, overwhelming
evidence that data for this one study was collected in 1989 at the
subject's former university and with the aid of funds from her NSF
grant.
The subiect s u ~ ~ l i e dOIG with a manuscript entitled
described on the title page as Inan expanded version of a paper
presented at the annual meeting of the 0 - J
Associationm in 1992. This manuscript is based on the data from
(study #3), another of the ancillary studies. A manuscript
with a very similar title and list of authors is listed on page 11
of the curriculum vitae that the subject supplied to us in March,
1994 as submitted for publication.
I The subject supplied reimbursement receipts and assent forms
for a study on (study # 4 )
that indicate that data collection took place in 1989. Her
(continued. . . I
page 7 of 24
In January, 1990, the subject assumed a visiting faculty
position at her current institution. At that point, she had only
one research assistant working for her, and both the subject and
her assistant state that the assistant was not engaged in data
collection (See her Affidavit in Appendix 3 and her research
.
-
assistant's statement in Appendix C) Both also state that the
assistant left the subject's employ by the end of the month.
Between February 13, 1990 and April 9, 1990, the subject
withdrew $3250 from her checking account in five checks made out to
herself and one made out to cash. Memo lines on three of the six
checks refer tofI- one of the subject's ancillary studies.
One memo line refers to the subjectls label for the
study supported by NSF, and another to an unspecified "Research
studyI1 (See Appendix P).
The subject could supply .no documentation that these
expenditures were made to reimburse research participants. In her
affidavit (page 2), she stated that "these monies went to s
reimbursement for participants in the
Study, to the best of my recolle~tion.~She produced nothing of
substance to support this claim. She supplied OIG with an undated
log with the names and addresses of 40 potential research subjects
who lived near her new institution. Information in the log
indicates that the persons listed were potential participants in
other evidence, however, indicates that this,log refers
to persons who, if they participated in the study, did so long
after the subject made her withdrawals from.herchecking account in
early 1990. The subject supplied reimbursement receipts and
consent forms from participants in the study who were interviewed
after the subject moved to her new institution. All 16 such
receipts were signed by people listed in the subject log. With one
exception (a receipt dated May, 1990), these receipts are dated
between November 1990 and May 1991. The subject supplied OIG with
extensive records of data collection for two of her other ancillary
studies, and partial records for- The research assistant who
worked o n stated that she herself kept some of the records
for that study. The absence of any documentation to support the
subject1s claim that she collected data for in the period
between February and April, 1990, contrasts strikingly with the
wealth of documentation she was able to supply concerning her other
3 ( . ..continued)
curriculum vitae lists a manuscript i>y 1 0 - ,
and on this topic; the third author is presumably the
rese-stant of the same name who collected data for this
project in 1989. OIG did not request a copy of this manuscript.
page 8 of 24
ancillary studies and her other activities with regard
itself.
The research assistant who did most of the data collection for
reported to the Special Review Board that the subject
interviewed ''about 20" persons for the study after moving to her
new institution (Appendix C; see also ,Appendix L) .4 Neither the
subject nor the research assistant has ever claimed that the bulk
of the data for this study were collected by the subject once she
arrived at her new institution; the research assistant originally
estimated that eighty percent of the data collection was done by
the research assistant. This claim is consistent with the numbers
of consent and assent forms and payment receipts from participants
who lived near the subject's new institution that the subject
produced during the visit by OIG investigators.
OIG believes that the preponderance of the evidence indicates
that the subject's data collection activities for- after she
moved to her new institution were restricted to a small number of
the total of 168 participants in the study. Insofar as there is
evidence of data collection for this study, that evidence shows
that data collection occurred either far from the subject's new
institution or well after April, 1990. Data collection activities
for this study cannot account for the withdrawals from the
subject's bank account in early 1990. The subject's claims to the
contrary are not credible.
OIG further believes that it is wholly implausible that the
subject could have spent this amount of money on participant
reimbursement in this amount of time. The subject had recently
arrived at a new institution. She had no paid research assistants
engaged in data collection. She was thus working alone or with
volunteers whom she had only recently met.' Even assuming a
4~ppendixL contains a letter from the same research assistant
" in which she discusses her activities. In that letter, the
research assistant says that she cannot recall the number of
participants that the subject interviewed after moving to her new
institution. She also reports that she had records of at least 42
interviews conducted before the subject's move. In the subject's
own records of data collection for this study, OIG discovered
consent forms and payment receipts from the research assistant
dated after the move, indicating that the research assistant
continued to collect data for this study after the subject
relocated.
he subject provided no evidence that she had recruited and
trained the large corps of volunteers that would have been needed
to do this work.
page 9 of 24
generous rate of $20 per research participant6 and $250 for
interviewer travel, the subject would have to have interviewed 150
persons in two months to generate $3250 in expenses. In the
-
previous calendar year, working with three paid assistants (see
breakdown of research assistant expenditures, Appendix 5) and
several student volunteers (see Affidavit, Appendix 3, page 3) , the
subject collected data from approximately 250 secondary school
students and a handful of adult^.^ She reports that her paid
assistants were responsible for the bulk of this data collection
(Affidavit, Appendix 3, page 2). The study designs that her
assistants and she executed while she was still at her former
university had much less stringent participant selection criteria
than either or the study design that was proposed to NSF.
The latter two studies required participants in specified family
configurations, whereas the former did not. To believe the
subject's account would be to believe that, in contrast to her
performance under more favorable conditions the preceding year, she
carried out an enormous amount of data collection in a short period
of time under a demanding research design without the aid of
research assistants working under the grant. Although the subject
was able to produce extensive documentation of her research and
' expenditures for the studies performed while she was still in
residence at her former university, she could not produce
comparable documentation-- or, indeed, any documentation at all--
of the activities that generated her expenditures in the early
6 ~ h i sis much higher than in her studies at her former
university, but using adult subjects rather than high school
students would have necessitated a higher reimbursement rate. In
her affidavit (appendix 3) , she says that she increased the subject
reimbursement rate from the $10 that she proposed to NSF to $20.
7 ~ h i sestimate is based on the assumption that data from two
ancillary studies, one with 72 secondary school student
participants and the other with 160 secondary school or college
student participants, were collected entirely during 1989 at the
subject's former university. An indeterminate number of J ,
subjects were also interviewed during this year; a plausible
estimate is 100, although the number might be as low as 50. A
study of adolescents1 - was also
conducted
s i , tatn some
i o p no documentary evidence that
this was in 1989. Data collection for this study appears to have
been done after the subject arrived at her new institution. The
subject maintains that she collected data from 91 four person
families while she was still at her former institution, but OIG
I believes that this claim is false (see above, page 6, and below,
page 17). There is evidence that she collected data from up to
nine such families in 1989, however (see below, page 18).
page 10 of 24
months of 1990. OIG believes that the subject's story is simply
not credible.
OIG concludes that the subject misused funds set aside for
human subject reimbursement. She departed from the procedures for
using her bank account that she described in the special
justification she submitted to her former university (see
Appendix J) in that she typically wrote checks to herself or her
research assistants and not directly to research participants. In
addition, although the subject states that these funds were used
for research related purposes, we were unable to locate any
documentary evidence to establish how the funds were actually used.
2. Failure to account for video equipment
The Special Review Board report (Appendix- 1, pp. 20-21)
contends that the subject misspent .grant funds for unnecessary
video equipment:
. . . $869.39 was used to purchase a stereo television
monitor, a video cassette recorder, a TV/VCR stand, and
associated cables (the expenditure summary and purchase orders
are reprinted in Appendix P). The Board could not establish
a need for this equipment. . . . According to [a faculty
collaborator] s statement (~ppendixC) , video equipment was
used with a few pilot subjects in the study entitled 0
." It is not clear
-
i
de
o Tquipment p=by [the subjectl was
used with these subjects; suitable video equipment was
already available for use by members of [the subject's
department] at the time of the research. According to [name],
Chair of the Department, the equipment purchased by [the
subject] is missing from the Department.
This equipment, because it was purchased with grant funds, is the
property of the subject's former university. Even if it had been
necessary for the subjectts research, the subject would have had no
' right to take it from the university without permission.
On page 5 of her affidavit (Appendix 4), the subject offers
the following account of this matter:
The equipment I purchased (I believe with NSF funds) for the
Study [referred to
fo- this
hc-per included an RCA
VCR, a VCR cart, an RCA television monitor, and two cables,
were left by me in my lab when I came to [her new state] in
January 1990. I do not know what happened to this equipment;
when I went back to [the University] in June 1991 to pack up
my lab and office, the equipment was missing. I informed [a
page 11 of 24
faculty colleague] of this when we met in June 1991 to review
which equipment belonged to me and which to [the university].
I felt it necessary to purchase this equipment for the
Study because I could not perform the
ipment, as three sets of TVs, VCRs, and
cables were needed, and only two were available in [the
faculty collaborator] s lab.
The subject further explained that other video equipment in her
former department would not have been readily available for her
' research, as it was housed in other laboratories and under the
control of other researchers. From the subject's description of
the research design in which the video equipment was to be used,
OIG believes it is probable that the equipment was originally
purchased for a legitimate research purpose, but not for urposes
of executing the study design originally proposed to NSF.f'
OIG believes that the evidence from our investigation tends to
confinn the university1s conclusion that the subject failed "to
secure the safekeeping" of equipment belonging to the university.
3. Treatment of human subjects
The IRB at the subject's former university issued a report
(Appendix2) concerning the subjectlsviolations of IRB guidelines.
This report is essential reading for making decisions concerning
this case. The sections of the Special Review Board report
relating to human subjects violations (Appendix 1, chiefly pages 7-
11, page 15, and page 19 and the report appendices referred to
therein) also provide supporting documentation for the IRB
findings.
Of the seven violations of IRB guidelines listed in the IRB
report, five, in OIG1sopinion, might reasonably be seen as serious
deviations from accepted practice in the scientific community and
hence as misconduct in science under NSFrsdefinition. Because two
of the IRB findings concern the same kind of violation ( # 3 and # 4 ) ,
we have grouped them together. The serious violations are:
'When OIG interviewed the subject at her home, OIG staff
noticed in plain view video equipment that appeared to be identical
to that purchased with grant funds. The subject states in her
affidavit (Appendix 3, page 5) that "though I have an RCA VCR in my
home which matches the description of the VCR purchased for the
Study, I will not give [the OIG staff member] my consent to inspect
it to determine if it is the same as that purchased under the
grant. "
page 12 of 24
1. Failure to respond to IRB request for consent and
assent forms. (1)
2. Failure to pay research participants as promised.
(2
3. Failure to obtain written consent from two school
systems to perform research using their students.
(3) and (4)
4. Failure to obtain IRB approval for data collection
protocol. ( 7 )
(Numbers in parentheses refer to the numbered IRB findings in
Appendix 2). The remaining two violations, even:considering that
human subjects regulation is generally extremely rule and detail
oriented, cannot reasonably be construed as serious enough to
warrant a finding of misconduct in science and will not be
discussed further. In her affidavit, the subject discusses her
response to the findings in the report (Appendix 3, pp. 3-41.
Regarding the first finding, the subject admits she was
unresponsive to her former university's IRB. She explained that a
hostile environment and a poorly handled tenure review process had
left her ndepressedllso that she "reacted stupidlyn (Affidavit,
Appendix 3).
OIG notes that there is ample documentation that the subject
repeatedly failed to cooperate in IRB and IRB related
investigations concerning her treatment of human subjects (see
Special Review Board Report, pp. 1-8, and Appendices D, E, and F).
The evidence clearly indicates that the subject knowingly failed to
respond to legitimate information requests from her former
university's IRB. The subject admits that she received these
requests and did not respond to them.
Regarding the second finding, the subject says it was
llpossiblell
that research participants who claimed not to have been
paid as promised were noverlooked. She claimed that, on one of
the several occasions on which her department chair contacted her
" about this matter in October and November of 1990, she offered to
pay these participants (Appendices A and G bear on this claim, but
do not corroborate it).
OIG' s examination of the subject's payment records revealed
that all three complainants participated in an abortive study that
combined the study design the subject proposed to NSF with the
" collection and analysis of videotaped family interactions. The
subject initiated this latter project in'conjunction with a faculty
collaborator who left the subject's former university for another
page 13 of 24
institution. For the other studies that OIG believes the subject
conducted using funds from her NS-F awirdl9the subject has G p l e
records of participant payment.
OIG believes the preponderance of the evidence indicates that
the payment problem was restricted to one abortive study. We do
not believe there is strong evidence to relate this problem to the
subsequent misuse of funds from the bank account the subject
established to reimburse research participants, except insofar as
her failure to pay the complainants meant that there was additional
money available for misuse that remained in the account.
I The preponderance of the evidence indicates that the subject
was at least grossly negligent in not paying research participants
in her study. The subject was an experienced researcher and a
former IRB member. She was well acquainted with the rules for
proper treatment of human subjects. Even for an aborted study, she
should have had a system in place for maintaining records of
research participation and sending promised-payments. She had a
convenient source of funds in her university authorized checking
account, but failed to use these funds for their intended purpose.
When alerted to her failure to pay her research subjects, she did
not act affirmatively to remedy this failure, although she may have
made general statements of her intention to pay. Her pattern of
action in failing to pay her research subjects shows a gross lack
of care that OIG believes is sufficiently blameworthy to justify a
finding of misconduct.
Regarding the issue of school system approval, the
preponderance of the evidence indicates that the subject failed to
obtain approval from one school system whose students she solicited
as research participants.1° Although the subject claims to have a
his includes the three completed ancillary studies:
and V - - - -
,
, The
q 1 9 8 9 with the support of her NSF grant she
executed both the original study design she proposed to NSF and a
study of adolescentst . She lacks
documentation of participant reimbursement for these studies, but
that, in our view, is because she did not do them when she says she
did. It is not because she failed to pay the persons who in fact
participated. The evidence to support OIGtsconclusions about what
research the subject conducted in 1989, while receiving NSF
support, is discussed below (pp.14-17).
'Qegarding the other alleged instance of failure to obtain
school system approval, the situation is as follows: the IRB found
that the subject failed to get school system approval for
(continued.. .)
page 14 of 24
copy of an approval from the public school system near her former
university, she was unable to supply a copy of this approval. She
did supply two forms containing requests "for approval of research
study to be conducted in the [name] County schools." The subject
herself had signed these forms, but they had not been signed by an
official of the school system. She also supplied a letter, written
on)the stationery of her former department and dated January 20,
1989, addressed to an administrator at the school system in
question. This letter thanks the administrator for meeting with
the subject and expresses the subject's hope "to work with you on
the research which we disc~ssed.~ The letter describes two
projects that were discussed in the meeting: one of the ancillary
studies and the study that was proposed to NSF. While this letter
is evidence that the subject attempted to obtain school system
approval for conducting her research in the schools, it does not
show that she actually obtained such approval.
OIG believes that the absence of a signed approval form in the
records of either the subject or the IRB at her former university
indicates that the subject did not obtain written approval and so
could not have filed an approval form as required by the IRB.
The subject was at least grossly negligent in not obtaining
school system approval for data collection involving students and
not filing notification of approval with her university's IRB.
Researchers who collect data in schools have a responsibility to
know the importance of mintaining good relations with them and the
importance of treating them properly. Because obtaining
documented school approval for data collection is so important,
neglecting to obtain it should not be considered merely careless.
The finding of data collection without an approved protocol
concerns the subject's study of
(referred to on page 4 as study # 5 ) . OIG concludes that data
collection for the study in question did not take place with the
aid of the subject's NSF award and did not take place when the
subject was at her former university, despite the subject's
testimony to the contrary. The subject has no documentary record
. ..
lo ( continued)
soliciting research participants at the schools near her current
institution. The subject contends that she Ifgotsubjects through
advertisements in the newspaper and in flyers, not through
schools.I' Neither OIG nor the Special Review Board has any
substantial evidence to contradict the subject's claim on this
point; the contrary impression seems to have developed from
remarks the subject made to university officials concerning data
collection that took place after she moved to her new institution
(see Special Review Board Report, p.11; see also Appendix GI.
page 15 of 24
of consent forms or subject reimbursement for 1989 concerning this
study, nor did any of her research assistants testify to their
involvement in it. The subject does have published reports of data
from this study, however. These are co-authored by graduate
students at her current institution and a peared long after she
ceased spending money under her NSF award.'' Although the subject
acknowledges NSF support for this study, we believe that, at most,
NSF supported planning for the study and not actual data
collection. Because we conclude that the data collection in
question was not aided by the NSF award, we have no reason to
consider possible noncompliance with human subjects guidelines in
this study.
4. Non-performance of research
The Special Review Board concluded that in 1989 the subject
did not perform the research she proposed to NSF. The evidence
that the subject supplied to OIG during our interview tends to
confirm this conclusion. We believe that the preponderance of the
evidence indicates that the subject began collecting data for this
study in the late summer or fall of 1989, but that she collected
data from only a small number of subjects.
The earliest written record that the subject could supply for
a data set matching the data sek she proposed to collect under the
study design described to NSF was a codebook dated November 25,
1991.I2 OIG believes this codebook supports the subject's claim
are based on this st6iy.
-
h he subject supplied reprints -
of two published reports
- that
--
,- pp. 0 ; Y n bd- w
w;dp.in-th are o - a u t h z
cuerent institution. In one, she describes subject recruitment as
having taken place through newspaper and radio advertisements,
which is consistent with how she elsewhere described. subject
recruitment as taking place when she arrived at her new
institution.
121t was prepared in SPSS-PC (Statistical Package for the
Social Sciences) format. The codebook contains a list of all the
variables for which the subject collected data, and the variables
listed match those that would have been collected under the study
design proposed to NSF. The subject
conference paper entitled - -
page 16 of 24
that she performed the research, while at the same time
contradicting her claim about when she did it. We do not, in other
words, believe there is reason to think that she has fabricated
data. We believe it is extraordinarily unlikely the subject would
have fabricated a 1991 codebook to substantiate her claim that she
collected these data in 1989, when she did not fabricate more
-
direct evidence of 1989 data collection.
The Special Review Board found that none of the subject's
research assistants reported collecting data under the study design
proposed to NSF. The subject supplied OIG with an article from a
local newspaper in which she describes her research and presents
herself as seeking suitable participants for further research. The
subject emphasized to OIG that she had checked the article for
accuracy before it was published. The article is dated
1989. It represents the subject as having ttrecentlyfinishedn two
of the ancillary studies (#2 and #4) and as having a third one ( # 3 1
under way." It presents her as "currently looking for additional
volunteers for her studiesttand says that "she needs approximately
100 families for the current round of testing." This description
is consistent with the idea that in late 1989, the subject
had not yet b e y n collecting data under the study design she
proposed to NSF. The subject also provided OIG a copy of a letter
--
I - and 4.- - . This paper
- - ik identified on the
title page
- - as "a revised version of a poster presented at the
biannual meeting of the -
1993. It contains data from "364
participants- 91 mothers and fathers, and two of their biologically
related children. It This description matches the subject's
description of the data she collected under the study design she
proposed to NSF.
13~hese descriptions are consistent with other evidence
concerning the subject's data collection activities, including the
subject's records of participant reimbursement and the signed
consent and assent forms from these studies.
141f this inference is correct, it further undermines the
subject's claim in her affidavit that in 1989 she used the money
from her subject reimbursement account to pay families that
participated in research under the study design proposed to NSF.
From the beginning of July, 1989, to the end of the year the
subject withdrew $510 from that account. Of this amount, $490 was
paid in checks to the research assistant who ran the -project
and $20 was paid directly to subjects who participated in that
..
(continued. )
page 17 of 24
to the same newspaper, dated 1989, concerning an
advertisement she wished to run to recruit research participants.
This further supports the idea that she was early in the process of
recruiting subjects for the NSF funded study."
For the project that was funded by NSF, the subject supplied
OIG with consent and assent forms signed by 27 members of nine
families. These forms indicate that the subject planned to
coordinate the research plan that she had developed with her
faculty c~llaborator'~ with her research under the NSF study
design. The forms describe a two step data collection procedure,
the first step of which matches the study design for the study
, proposed to NSF and the second step of which matches the design for
the study with the subject's faculty collaborator. The forms state
that "each family member will be paid $10.00 for completing Phase
I, for a possible total of $40.00 per family (i.e., both parents
and up to two teenage children)..I1 An equivalent amount was
promised for completion of the second phase of the study.
Included among the consent and assent forms the subject
supplied to OIG are the forms signed by all three of the
complainant families. One complainant family claims that it is
owed forty dollars, while another claims it is owed thirty dollars
(see Appendix H) . These amounts suggest that these families did ' I
not participate in both phases of the study. This is consistent I
with the collaboratorIs statement (Appendix C) that few if any I
subjects actually participated in the study that she and the
subject designed.
The testimony of these participants as to the research process
was, according to the Special Review Board report, lathe only
evidence of data collection activity on this projectn (pp. 9-10).
( . . .continued)
14
project. The research assistant, according to both the subject and
the assistant herself, was not involved in executing the study
I
design the subject proposed to NSF.
he Special Review Board was unable to locate and interview
one of the subject's research assistants. OIG was also unable to
locate him. This assistant left the subject's employ before July.
We therefore believe it is highly unlikely that he collected any
significant amount of data under the research design proposed to
NSF.
!I 16This is the study of
.purchased. It is this studmr which the v w e q u i p m e n t was
The newspaper article also describes this as a study on
which the subject was currently working.
page 18 of 24
The signed consent and assent forms do not necessarily indicate
that the signatories actually participated in the subject's
research; the forms indicate only that the signatories agreed to
participate.
OIG believes that the small number of consent and assent
forms, the absence of research assistants who might have
administered data collection or taken part in subject recruitment,
' and the absence of other evidence of data collection while the
subject was in residence at her former university make it unlikely
that in 1989, while receiving and spending NSF grant funds, the
subject collected the data for the project that she proposed to NSF
and that NSF funded.
5. Non-Cooperation with Inquiries and Investigations.
OIG1s investigation did not uncover additional information
I relative to the subject's failure to cooperate with inquiries and
investigations by her former university. The Board report
discusses this issue on pages 8 and 21; *further evidence can be
found in Appendices D l E l and F.
Evidence Bearing on an Additional Allegation
The Special Review Board raised an additional allegation (p.
21) by one of the subject's graduate assistants that the subject
npersuadedher to relocate to [the subject's new institution] under
false pretenses: by promising her admission to the school and a
full-time salary on the NSF-funded projects. Neither promise was
fulfilled, and [the student] claims she is owed $1400 for services
rendered.
Because this allegation relies on the testimony of the
parties, and cannot, for the most part, be verified by documentary
" evidence, it is a difficult allegation to substantiate and relies
heavily for substantiation on the complainant's credibility.
In her affidavit (Appendix 3, page 4), the .subject disputes
the student's account of the events that took place after the
student moved to the subject's new state and resumed working on the
subject's research project. She states that the student "never had
an intention of enrollingn at the subjectls current institutionvv
and "after the summer of 1989, she had decided to discontinue
graduate studies in Iv at the subjectls former university.
The subject told OIG-gators that the student was planning
to apply to medical school and had been taking pre-medical courses.
OIG obtained a copy of the student's transcript and verified that
the student was taking pre-medical courses and not
courses in her final semester at the subject's former-u
page 19 of 24
OIG believes that this evidence casts sufficient doubt on the
credibility of the student's claims of non-payment to make it
impossible to meet the burden of proof necessary to substantiate
this allegation.l7
OIG8s Conclusion Regarding Misconduct in Science
NSF defines misconduct in part as llfabrication,falsification,
plagiarism, or other serious deviation from accepted practices in
proposing, carrying out, or reporting results from activities
funded by NSFn ( § 689.1(a) (1)).
OIG1s investigation addressed those acts of the subject that
fall within this definition, those acts that her former university
considered to be "scientific misc~nduct,~ and one additional
allegation noted by the Special Review Board. Following the
university's recommendation, O I G interviewed the subject and
examined her research records. The additional information
generated by our investigation, while it has led us to revise or
expand upon some of the university's . factual findings, does not
cause us to question their overall conclusions. Specifically, we
, agree with the university that the subject violated the usual and
customary practices for treating human subjects, misused grant
funds, failed to secure the safekeeping of university owned
equipment purchased under the grant, failed to use her NSF award to
conduct the study she proposed to NSF, and refused to cooperate
with inquiries and investigations into the allegations directed at
her.
We share the university's view that, taken together, the
subject's failures to comply with human subjects regulations are a
serious deviation from accepted practices for the treatment of
human subjects ( § 689.1 (a)(1)) and constitute misconduct as defined
in NSF1s regulation on misconduct in science and engineering.
OIG believes that the subject's failure to respond to IRB
requests for information, failure to pay research participants as
promised, and failure to obtain school system approval for research
using the system's student population seriously deviate from
accepted practice in the community of researchers that studies
human beings. Condoning acts such as these would undermine the
authority of the system of human subjects regulation that the
federal government supports and oversees, erode the trust necessary
his is not to say that OIG accepts that the subject's
account is therefore accurate. We clearly have ample reason to
question the subjectls credibility as well. We simply concluded
that this allegation was unproven and unprovable.
page 20 of 24
for researchers to recruit subjects for their research, and
! ultimately threaten research subjects with significant harm. At
the time when the subject's NSF supported research was conducted,
NSF1s definitTon of misconduct (45 CFR § 689.1 (a)) specifically
included "material failure to comply with Federal requirements for
protection of researchers, human subjects, or the public.w18
All institutions that receive federal funds to perform
research involving human subjects are required to have IRBs that
set guidelines for the proper conduct of such research and monitor
compliance with those guidelines. The primary activity of IRBs is
to educate researchers at their institutions about the proper
treatment of human subjects and to work with them to develop
research protocols that enable scientists to achieve their research
objectives while protecting the interests of human subjects.
OIG believes that federally mandated IRBs are at the core of
the effort to protect human subjects .from abuse and that repeated
failure to cooperate with a legitimate request from an IRB can be
misconduct in science. We believe that the subject's failure to
cooperate with her former university's IRB is her most serious
violation of human subjects regulations. We note that the Office
for the Protection from Research Risks (OPRR) at the U.S.
Department of Health and Human Services (HHS), which oversees
" federally funded research involving human subjects, stresses that
his language was dropped in May, 1991, and was therefore no
longer part of the definition when the Special Review Board and the
IRB carried out their investigations. In the Federal Register, NSF
explained that the language was omitted because it was deemed
nunnecessary.n It characterized the deleted types of misconduct as
"either . . , subject to other enforcement procedures and penalties
or . . . covered by the 'other serious deviation from accepted
practices1 language in the first clause of the definition of
'1 misconduct. (Vol. 56, No. 30, February 13, 1991). Thus the history
of NSF's definition of misconduct supports the idea that serious
violations of rules protecting human subjects are included in the
definition.
Sanctions against individual investigators have overwhelmingly
been left to the IRBs, which have acted without direct federal
government involvement. Where, as in the subject's case, an
investigator moves to a new institution, however, the I R B of the
former institution is powerless to take meaningful action . In such
situations, only the granting agency can act to uphold the IRB1s
authority. The subject' s actions clearly are not covered by "other
-enforcement procedures and penaltiesn that were referenced in the
Federal Register when the wording of NSF1s misconduct regulation
was changed.
page 21 of 24
investigator noncompliance with legitimate IRB requests is a
serious matter:
The most common lapses in investigator compliance include
unreported changes in protocols, misuse or nonuse of the
informed consent document, and failure to submit protocols to
the IRB in a timely fashion. . . . 'Occasionally, an
investigator will either avoid or ignore an IRE, Such cases
present a more serious challenge to the IRE and to the
institution, Regardless of investigator intent, unapproved
research involving human subjects places those subjects at an
unacceptable risk. When unapproved research is discovered,
the IRB and the institution should act promptly to halt the
research, assure remedial action regarding any breach of
regulatory or institutional human subject protection
requirements, and address the question of the investigator's
fitness to conduct human subject research. Beyond the obvious
need to protect the rights and welfare of research subjects,
the credibility of the IRB is clearly at stake. [emphasis
added] .l9
OIG believes that keeping promises to research subjects and
obtaining informed consent from institutions that control access to
subjects are core IRB concerns and core aspects of respecting the
dignity of research subjects. Failures in these areas can also be
considered misconduct. The consequences of the subject s
wrongdoing go beyond the sheer loss of money by a small number of
research participants 'because the subject's acts challenge
important and generally recognized principles for how human
subjects ought to be treated.
OIG believes that the preponderance of the evidence supports
the findings that the subject committed culpable acts and that she
did so with a culpable state of mind. OIG concludes that the
subject committed misconduct as defined in NSF1s regulation on
Misconduct in Science and Engineering and recommends that NSF make
a finding to that effect.
OIG' S RECO-ED. DISPOSITION
When NSF makes a finding of misconduct, it must consider the
seriousness of the misconduct in determining what actions it should
take ( § 689.2(b)) . This includes considering the state of mind
with which the subject committed misconduct and whether the
misconduct IVwasan isolated event or part of a pattern.IV We have
190~~12,Protecting Human Research Subjects: Institutional
Review Board Guidebook, 1-15-16 (1993).
page 22 of 24
already explained that we conclude that the subject's human
subjects violations are a serious deviation from accepted practice
and hence are misconduct; this section explains OIG's recommended
actions in light of our assessment of the seriousness of the
subject's misconduct, i.e., of how serious this instance of
misconduct is in relation to other instances.
We believe that the subject's failure to respond to her former
university's IRB and to act affirmatively to rectify complaints
from human subjects is serious. The subject's actions broke faith
with both her research subjects who were not paid and with the
community of researchers who study human subjects. It is not
merely a bending of established rules, as when the subject's
research assistant elicited consent orally rather than in writing
or when the subject failed to obtain permission to do research from
all relevant IRBs. The subject has clearly challenged key tenets
of human subjects protection, even though the harm to individual
subjects that resulted was relatively small.
We do not believe that the subject committed her misconduct
out of deliberate contempt for either human subjects or human
subjects regulation. This would be a far more serious offense if
it were motivated by such contempt. Rather, we believe the offense
was a by product of the subject's alienation from her former
university and her desire to avoid confronting her own financial
transgressions. We do not in any way believe that these
motivations excuse the subject's actions.
We do not believe that the non-payment of research
participants was part of a pattern of non-payment. When we read
the Special Review Board report, we thought it likely that many
subjects were not paid, but did not complain. The evidence we
developed in our interview with the subject and our examination of
her files leads us to conclude that the three complainant families
were among a very small number of families interviewed for an
aborted study and are not symptomatic of a pattern of non-payment .
of subjects. In the studies the subject executed in 1989 at her
former university, she otherwise appears to have paid her subjects.
We also believe, however, that the subject manifests a pattern
( f i 689 - 2(b)(3)) of non-compliance with NSF grant conditions that
warrants special attention if and when the subject receives another
grant. There are numerous indications of this non-compliance: her
decision to use the NSF grant to perform her ancillary studies,
rather than to follow the study design she proposed to NSF; her
misuse of funds from a bank account that was specially designed to
enable her to compensate research participants; and her failure to
page 23 of 24
secure the safekeeping or return of equipment that was the property
of her former university are the outstanding examples.20
Because we believe that the subject's non-compliance with
a
rules for the protection of human subjects is part of a pattern of
non-compliance with NSF grant conditions, we recommend that NSF
take special steps to ensure that the subject comply with NSF grant
conditions in the event that she receives another award. We do not
believe the subject's misconduct should prevent her from competing
for future awards. However, we recommend that until January, 1998,
before NSF makes an award in which the subject is named principal
investigator, NSF management should require that the grantee
institution establish special procedures to monitor the subject's
compliance with NSF's grant conditions. These procedures should
include, but should not necessarily be limited to, procedures for
monitoring her compliance with human subjects regulations at the
grantee institution.
We recommend a finding of misconduct under NSF' s Regulation on
Misconduct in Science and Engineering. We recommend two actions by
NSF in response to the subject's misconduct. The subject should be
11 sent a letter of reprimand, which is a Group I action (see
§ 689 2 a 1 (i)). If the subject is named principal investigator
on an NSF award, NSF should require that the grantee institution
establish special procedures to monitor the subject's compliance
with NSF's grant conditions (see preceding paragraph). This may
involve a combination of Group I and Group I1 actions (see
§ 689.2(a)(l)(ii), § 689.2(a)(l)(iii), and § 689,2(a)(2)(ii)). We
believe these actions adequately protect NSFrs interests and are
proportionate to the misconduct by the subject.
*%e note that the subject appears to have communicated her
casual attitude to the rules of the scientific community to her
research assistant, who responded by unilaterally altering IRB
approved procedures for obtaining consent from research
participants (see IRB finding #6, Appendix 2).
page 24 of 24
Grant Fraud Human Subject Reg. Violations
Published by the National Science Foundation, Office of Inspector General on 1995-10-16.
Below is a raw (and likely hideous) rendition of the original report. (PDF)